Indian scientists at the Delhi-based National Institute of Immunology have developed a new technology that could produce once in 3-month insulin injection for diabetic patients.
Currently, insulin is injected multiple times a day to control blood sugar in diabetes patients.
The new insulin formulation follows a simple technique in the hormone is clumped together into complexes called oligomers.
These oligomers are then injected into rats, mice, and rabbits with chemically induced diabetes. A single injection maintained basal glucose levels for up to 3 months, whereas other diabetic mice needed daily injections.The diseased mice mice not given insulin died within 40 days.
The NII researchers tested the oligomer insulin on mice and rabbits using bovine and recombinant human insulin. A single dose using bovine insulin was able to give coverage for over 120 days while that with recombinant human insulin sustained over 140 days.
The oligomers act like “an insulin depot” at the injection site, releasing a steady, low insulin dose, according to Dr Avadhesha Surolia, director of the National Institute of Immunology here, who led the research team.
“The just above basal level of human insulin released in a sustained manner has been found to be effective in not only controlling the upsurge in the level of blood glucose after meals, but also in preventing the dreaded early morning hypoglycaemia, which is caused by low glucose levels,” stated Dr Surolia.
The oligomer technique primarily involves getting individual molecules of insulin to come together and form multi-molecular or supra-molecular assemblies.
Oligomer insulin utilizes the basic principles of protein folding to harness the inherent aggregative property of insulin molecules to generate a form that exhibited a controlled and sustained release of the molecules over prolonged periods, explained Dr. Surolia, who is also a professor at the Bangalore-based Indian Institute of Science’s Molecular Biophysics Unit.
Since oligomers do not lead to the activation of enzymes that destroy insulin, it does not cause cancer which many currently available insulin analogues are associated with.
The researchers observed no side effects in the animal studies.
NII has transferred the technology to Life Science Pharmaceuticals in Darien, Connecticut for further development including clinical trials. The US firm plans to launch clinical trials to test the oligomr insulin later this year.
If it comes out successfully through all clinical testing, the oligomer based insulin could be available in the market in about six years after, Dr Surolia hoped.
A major issue with diabetes management with the current practice of multiple injections in a day was the fear of pricking oneself. This often lead to the patient not adhering to the treatment in toto, resulting in complications such as diabetic cardiopathy, cataract and nephropathy.